TrialCurveRATIONALE-306 (Japanese subgroup, 3-year): reconstructed Kaplan–Meier curves
First-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in adults with advanced or metastatic esophageal squamous cell carcinoma: a Japanese subgroup analysis of RATIONALE-306 with ≥ 3 years of follow-up. Curves rebuilt as patient-level data (Guyot 2012) and checked against the statistics printed on the figure.
| Publication | Esophagus. 2026 Apr 1;23(3):501–11. doi: 10.1007/s10388-026-01199-y |
|---|---|
| DOI | 10.1007/s10388-026-01199-y |
| Registry | NCT03783442 |
| Phase | Phase 3 |
| Conditions | Esophageal Squamous Cell Carcinoma (ESCC) |
| Interventions | Cisplatin, Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Paclitaxel, Tislelizumab |
| Sponsor | BeiGene |
| Enrolment | 649 |
| Source licence | Figure published under CC BY 4.0 |
Overall survival — Japanese analysis set (JAS)
From figure panel a · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Tislelizumab + Chemotherapy 24.4 months; Placebo + Chemotherapy 15.1 months. Survival at 18 months: Tislelizumab + Chemotherapy 67%; Placebo + Chemotherapy 45%. Hazard ratio Tislelizumab + Chemotherapy vs Placebo + Chemotherapy 0.75 (95% CI 0.43–1.30).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Tislelizumab + Chemotherapy | 33 | 26 | 24.4 |
| Placebo + Chemotherapy | 33 | 25 | 15.1 |
- Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: reconstructed HR 0.75 (95% CI 0.43–1.30)
Landmark survival (reconstructed)
| Time | Tislelizumab + Chemotherapy | Placebo + Chemotherapy |
|---|---|---|
| 6 mo | 90.9% | 78.8% |
| 12 mo | 84.8% | 54.5% |
| 18 mo | 66.7% | 45.5% |
| 24 mo | 51.5% | 27.3% |
| 36 mo | 24.2% | 24.2% |
| 48 mo | 20.2% | 24.2% |
Checks against the published figure
- Tislelizumab + Chemotherapy median: printed 24.5, reconstructed 24.4 pass
- Placebo + Chemotherapy median: printed 15.1, reconstructed 15.1 pass
- Tislelizumab + Chemotherapy events: printed 26, reconstructed 26 pass
- Tislelizumab + Chemotherapy n: printed 33, reconstructed 33 pass
- Placebo + Chemotherapy events: printed 25, reconstructed 25 pass
- Placebo + Chemotherapy n: printed 33, reconstructed 33 pass
- hazard ratio: printed 0.75, reconstructed 0.748 pass
Overall survival — JAS with tumor PD-L1 TAP score >= 10%
From figure panel b · validated against the values printed on the figure · curve source: vision model
Reconstructed from the published curve. Median: Tislelizumab + Chemotherapy 25.2 months; Placebo + Chemotherapy 16.8 months. Survival at 18 months: Tislelizumab + Chemotherapy 67%; Placebo + Chemotherapy 43%. Hazard ratio Tislelizumab + Chemotherapy vs Placebo + Chemotherapy 0.79 (95% CI 0.26–2.36).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Tislelizumab + Chemotherapy | 12 | 9 | 25.2 |
| Placebo + Chemotherapy | 7 | 5 | 16.8 |
- Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: reconstructed HR 0.79 (95% CI 0.26–2.36)
Landmark survival (reconstructed)
| Time | Tislelizumab + Chemotherapy | Placebo + Chemotherapy |
|---|---|---|
| 6 mo | 91.7% | 71.4% |
| 12 mo | 83.3% | 71.4% |
| 18 mo | 66.7% | 42.9% |
| 24 mo | 58.3% | 28.6% |
| 36 mo | 33.3% | 28.6% |
| 48 mo | 25.0% | 28.6% |
Checks against the published figure
- Tislelizumab + Chemotherapy median: printed 25.5, reconstructed 25.2 pass
- Placebo + Chemotherapy median: printed 16.8, reconstructed 16.8 pass
- Tislelizumab + Chemotherapy events: printed 9, reconstructed 9 pass
- Tislelizumab + Chemotherapy n: printed 12, reconstructed 12 pass
- Placebo + Chemotherapy events: printed 5, reconstructed 5 pass
- Placebo + Chemotherapy n: printed 7, reconstructed 7 pass
- hazard ratio: printed 0.79, reconstructed 0.786 pass
Overall survival — JAS with tumor PD-L1 TAP score < 10%
From figure panel c · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Tislelizumab + Chemotherapy 25.9 months; Placebo + Chemotherapy 11.7 months. Survival at 12 months: Tislelizumab + Chemotherapy 88%; Placebo + Chemotherapy 48%. Hazard ratio Tislelizumab + Chemotherapy vs Placebo + Chemotherapy 0.53 (95% CI 0.26–1.08).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Tislelizumab + Chemotherapy | 17 | 13 | 25.9 |
| Placebo + Chemotherapy | 21 | 18 | 11.7 |
- Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: reconstructed HR 0.53 (95% CI 0.26–1.08)
Landmark survival (reconstructed)
| Time | Tislelizumab + Chemotherapy | Placebo + Chemotherapy |
|---|---|---|
| 6 mo | 94.1% | 76.2% |
| 12 mo | 88.2% | 47.6% |
| 18 mo | 70.6% | 42.9% |
| 24 mo | 58.8% | 19.0% |
| 36 mo | 23.5% | 14.3% |
Checks against the published figure
- Tislelizumab + Chemotherapy median: printed 26, reconstructed 25.9 pass
- Placebo + Chemotherapy median: printed 11.8, reconstructed 11.7 pass
- Tislelizumab + Chemotherapy events: printed 13, reconstructed 13 pass
- Tislelizumab + Chemotherapy n: printed 17, reconstructed 17 pass
- Placebo + Chemotherapy events: printed 18, reconstructed 18 pass
- Placebo + Chemotherapy n: printed 21, reconstructed 21 pass
- hazard ratio: printed 0.53, reconstructed 0.527 pass
Progression-free survival (investigator assessment) — Japanese analysis set (JAS)
From figure panel · validated against the values printed on the figure · curve source: pixel measurement confirmed by vision model
Reconstructed from the published curve. Median: Tislelizumab + Chemotherapy 6.8 months; Placebo + Chemotherapy 4.5 months. Survival at 12 months: Tislelizumab + Chemotherapy 18%; Placebo + Chemotherapy 13%. Hazard ratio Tislelizumab + Chemotherapy vs Placebo + Chemotherapy 0.78 (95% CI 0.46–1.32).
| Arm | N | Events | Median (Months) |
|---|---|---|---|
| Tislelizumab + Chemotherapy | 33 | 27 | 6.8 |
| Placebo + Chemotherapy | 33 | 29 | 4.5 |
- Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: reconstructed HR 0.78 (95% CI 0.46–1.32)
Landmark survival (reconstructed)
| Time | Tislelizumab + Chemotherapy | Placebo + Chemotherapy |
|---|---|---|
| 6 mo | 57.6% | 35.6% |
| 12 mo | 18.5% | 12.9% |
| 18 mo | 7.4% | 12.9% |
| 24 mo | 7.4% | 6.5% |
| 36 mo | 7.4% | — |
Checks against the published figure
- Tislelizumab + Chemotherapy median: printed 6.8, reconstructed 6.82 pass
- Placebo + Chemotherapy median: printed 4.5, reconstructed 4.49 pass
- Tislelizumab + Chemotherapy events: printed 27, reconstructed 27 pass
- Tislelizumab + Chemotherapy n: printed 33, reconstructed 33 pass
- Placebo + Chemotherapy events: printed 28, reconstructed 29 pass
- Placebo + Chemotherapy n: printed 33, reconstructed 33 pass
- hazard ratio: printed 0.77, reconstructed 0.781 pass
About these data
Pseudo-IPD reproduces the published curves and numbers at risk; the rows are not real patients. Cite the publication (DOI above) and TrialCurve. The source figure is © the authors (CC BY 4.0); the charts here are redrawn from the reconstruction.
Load these data in R or Python
# R
library(survival)
d <- read.csv("https://trialcurve.com/data/trials/rationale-306-japanese-subgroup-3-year-1.csv")
survfit(Surv(time, event) ~ arm, data = d)
coxph(Surv(time, event) ~ arm, data = d)
# Python
import pandas as pd
from lifelines import KaplanMeierFitter
d = pd.read_csv("https://trialcurve.com/data/trials/rationale-306-japanese-subgroup-3-year-1.csv")
for arm, g in d.groupby("arm"):
KaplanMeierFitter().fit(g.time, g.event, label=arm).plot_survival_function()
Suggested citation: Esophagus. 2026 Apr 1;23(3):501–11. doi: 10.1007/s10388-026-01199-y doi:10.1007/s10388-026-01199-y. Reconstructed data: TrialCurve (2026), https://trialcurve.com/trials/rationale-306-japanese-subgroup-3-year
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